OT-Nocturia study

Phase 3

• Conditions: nocturia; D053158

• Registration Number: JPRN-jRCTs051180071
• Lead Sponsor: Ito Haruki

Brief Summary

In patients with nocturia, NoT did not result in a significant difference for nocturnal bladder volume. In contrast, it resulted in a significant decrease for nighttime frequency.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-21
• Study Completion: 2021-07-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1)Patients who has to wake at night more than twice for voiding
2)Patients who has a proper comprehension and compliance
3)50 years old or more patients
4)Patients with ECOG PS 0-2
5)Patients who go to a hospital regularly

Exclusion Criteria

1)Patients with polyuria
2)Residual urine volume is more than 200mL
3)Patients with benign prostatic hyperplasia, over active bladder and neurogenic bladder, who need the treatment other than nocturia
4)Any other patients who are regarded as unsuitable for this study by the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change of nocturnal functional bladder capacity

Secondary Outcome Measures

Name	Time	Method
IPSS/PSQI score, The change on frequency of urination at night, The change of nocturnal urine volume